Symbiosis Pharmaceutical Services has completed a successful inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA), further strengthening its regulatory credentials following the recent expansion of its manufacturing footprint.

The inspection focused on the company’s new GMP manufacturing site, a 20,000 sq ft facility designed to support the sterile fill/finish of injectable drug products, including small molecules and biologics. The site houses an automated aseptic fill/finish line and is part of a wider £26 million investment aimed at increasing Symbiosis’ commercial-scale capabilities amid continued demand for specialist aseptic manufacturing.

The new facility – known internally as the Bruce Building – has been formally incorporated into the company’s MHRA licence portfolio. In addition to fill/finish operations, the site includes GMP quality control labs and aseptic processing suites, enabling end-to-end support from clinical trial supply to commercial manufacture.

“This extension of our current MHRA licenses reflects the strength of our team and the robustness of our quality systems,” said CEO Colin MacKay. “For our clients, this solidifies confidence in our ability to accelerate the delivery of their sterile drug products to patients worldwide within a tightly regulated landscape.”

Symbiosis has passed multiple inspections by both the MHRA and FDA since its founding in 2011, and says its latest expansion aims to offer increased capacity for the development and supply of advanced therapies, cytotoxic products, and high-potency compounds.

The facility is designed to handle a range of fill/finish batch sizes, from early clinical to commercial scale, and supports GMP storage, labelling, packaging, and product release.